The Outcome of Technical Intraoperative Complications Occurring in Standard Aortic Endovascular Repair

Background Technical intraoperative complications (TICs) may occur during standard endovascular repair (EVAR) with possible effects on the outcome. This study evaluates the early and midterm effects of TICs on EVARs. Methods All EVARs (from 2012 to 2016) were analyzed to identify all TICs: (1) endoluminal defects (stenosis, dissection, rupture, compression of native arteries, or endograft); (2) type I-III endoleaks; (3) unplanned artery coverage; and (4) surgical access complications. Follow-up was performed by Doppler ultrasound/ontrast enhanced ultrasound/computed tomography scan at yearly intervals. The outcome was compared with that of uneventful cases (UCs) through Fisher's exact test and Kaplan-Maier curve. Results TICs occurred in 68 (18%) of 377 patients undergoing EVAR. Thirty-two endoluminal defects were relined endovascularly; 24 type I-III endoleaks were treated with cuff deployment/forced ballooning (23) and surgical conversion (1); 3 of 8 unplanned artery coverages were revascularized (2 renal and 1 hypogastric); 5 hypogastric coverages had an unsuccessful correction; and 4 access artery injuries were repaired. Although fluoroscopy time and contrast usage were significantly higher in the TIC group than those in the UC group (309 cases), 30-day outcome was similar for death (1.4% TIC vs 0% UC, P = 0.18), reintervention (0% TIC vs 0.3% UC, P = 1), type I-III endoleak (0% TIC vs 0.9% UC, P = 1), steno-occlusions (0% TIC vs 0.3% UC, P = 1), buttock claudication, and renal failure (0% in both groups). At 24 months, TIC and UC groups had similar survival (91.7 ± 8% vs 96.2 ± 2.1%, P = 0.5), freedom from reintervention (81.4 ± 9.9% vs 96 ± 2.2%, P = 0.49), overall complication rate (13.4 ± 7.6% vs 11.4 ± 3.5%, P = 0.49), type I-III endoleak (11.2 ± 7.5% vs 7 ± 2.9%, P = 0.8), buttock claudication (0% vs 2 ± 2% P = 0.6), and hemodialysis (0% in both). Midterm iliac leg occlusion was significantly higher in the TIC group (26.9 ± 12.3% vs 3 ± 2.1%, P = 0.01). Conclusion TICs may affect several aspects during EVAR, leading to the necessity of adjunctive maneuvers, which have no impact on early outcome but may cause an increased rate of midterm iliac leg occlusion

Abdominal aortic aneurysm treatment in Emilia Romagna region

Introduction. Elective endovascular repair (EVAR) of abdominal aortic aneurysm (AAA) has been performed with increasing frequency due to lower 30-day morbidity and mortality compared with open surgical repair(OSR). Similar advantages are reported for ruptured AAAs. Aim of the study was to report the frequencies of EVAR/OSR in elective and acute setting and 30-day outcomes, in two Italian Vascular Surgery of Emilia-Romagna-Region(VS-ERR). Methods. All patients undergoing AAA repair in two VS-ERR (2015-2019), were prospectively collected. Pre-operative, procedural and post-operative data were retrospectively analyzed. Percentage of EVAR/OSR were evaluated for overall, elective and acute patients. Technical-success (TS), intra-operative mortality and procedure-related adverse events (PAE) were assessed. Reinterventions, mortality&morbidity were assessed at 30-day. Results of EVAR and OSR were compared. Reasons of EVAR ineligibility were also investigated and compared. Results. Overall 878 patients underwent AAA repair, 736 in elective (EVAR/OSR:80.4%/19.6%) and 142 in acute setting (EVAR/OSR:71.1%/28.9%). Overall TS was 95.8%, PAE were reported in 9.1% of patients. Overall intraoperative mortality was 0.5%. Post-operative medical complications were reported in 21.2% patients. The mean hospitalization was 6.711.08 days. Overall 30-day-reinterventions and mortality were 3.9% and 4.2%, respectively. In elective-setting, TS was similar between groups(P=.18). OSR had more PAE(P<.001) vs EVAR. There was no difference of intraoperative mortality(P=.62). EVAR had shorter hospitalization(P<.001), less 30-day reintervention(P<.001) and mortality(P<.001) vs OSR. In acute-setting, no significant differences of TS(P=.56) and PAE(P=.18) between groups were observed. OSR had more perioperative medical complications(P<.001) and higher rate of 30-day mortality(P<.001) vs EVAR. The main reason of EVAR exclusion was anatomical unsuitability(94.4%) in elective-setting while logistic cause(61%) in acute-setting. Conclusion. EVAR has progressively increased for elective more than for acute setting. The misalignment of the VS-ERR from literature evidence in acute setting is principally due to logistic reason. According our data, the management of this subgroup of patients, should be improved

Intraoperative contrast enhanced ultrasound adds some important details to the endovascular aortic aneurysm repair completion control

BACKGROUND: The aim of this study was to evaluate the feasibility and utility of intraoperative contrast-enhanced ultrasound (CEUS) for early detection of endoleaks (ELs) during endovascular abdominal aortic aneurysm repair (EVAR) compared with completion digital subtraction angiography. METHODS: Patients undergoing elective EVAR from January 2017 to April 2018 were consecutively enrolled in this prospective study. After endograft deployment, two-digital subtraction angiography (2DSA) with orthogonal C-arm angulations (anteroposterior and sagittal view) were routinely performed. After the endovascular treatment of clear, high-flow type I/III ELs detected by 2DSA, intraoperative CEUS was carried out in sterile conditions on the surgical field before guidewire removal. Presence and type of EL were evaluated with 2DSA and CEUS. CEUS was performed with the vascular surgeon blinded to the 2DSA findings. The primary end point was the level of agreement between 2DSA and CEUS to detect any type of EL and type II EL. Agreement between two diagnostic methods was calculated using Cohen's kappa. The secondary end point was utility of CEUS for intraoperative adjunctive procedure guidance. RESULTS: Sixty patients were enrolled (mean age, 78 \ub1 6 years; 90% male). 2DSA revealed 11 ELs (18%; 1 type IA, 10 type II), and CEUS 25 ELs (42%; 2 type IA, 23 type II). 2DSA and CEUS were in agreement in 39 cases (65%; 32 no ELs, 7 type II ELs). CEUS detected 17 ELs not identified by 2DSA (28%; 2 type IA, 15 type II); 2DSA detected three ELs not identified by CEUS (5%; 3 type II). In one case, 2DSA and CEUS detected type II and type IA ELs, respectively. For EL and type II EL detection, Cohen's kappa was 0.255 and 0.250, respectively (both "fair agreement"). Intraoperative adjunctive sac embolization was performed under CEUS control in 4 cases and technical success was 100%. CONCLUSIONS: Intraoperative CEUS during EVAR is feasible and can detect a greater number of ELs than 2DSA, in particular type II ELs. Further studies are necessary to assess the reliability of this intraoperative diagnostic examination. In type II ELs, CEUS may represent an additional, useful tool for intraoperative sac embolization guidance

Influence of statin therapy on type 2 endoleak evolution

Background Endovascular repair (EVAR) for abdominal aortic aneurysm (AAA) is widely adopted; however, the procedure may be jeopardized by type 2 endoleak (T2E). Most T2Es regress over time, but their evolution is unpredictable. There is some evidence about the pleiotropic statin effect on AAA and thrombus stabilization, but there are no data on the influence of statins on T2E. The study's aim is therefore to evaluate a possible effect of statins on T2E evolution. Methods A retrospective analysis of patients discharged from 2008 to 2013 with T2E after EVAR was performed. Patients were followed up with duplex ultrasound and computed tomography angiography and divided on statin and no statin users. The primary end point was to evaluate the T2E persistence at 6 months and during follow-up. The secondary end points were to compare the shrinkage (median and rate), the sac increasing rate, and reintervention at 6 months and during follow-up. Results In the period examined, 756 EVARs were performed and 85 (11%) had T2E at discharge. Thirty-two (37%) patients with T2E were on statins. The median follow-up was 19 (interquartile range [IQR] 7) months. Statin and no statin patients had similar clinical and anatomical characteristics, endoprosthesis type, and medical therapy. At 6 months, patients on statins had lower T2E persistence ([26] 81% vs. [49] 93%, P = 0.16), reaching the significance at 36 months (11 ± 9% vs. 64 ± 7%, P = 0.001). By Cox analysis, statins are independently associated with T2E regression (hazard ratio 0.40, 95% confidence interval 0.020-0.81, P = 0.01), other characteristics are: >2 lumbar arteries or inferior mesenteric artery patency or oral anticoagulant therapy did not reduce T2E. At 6 months, statin patients had higher shrinkage rate and diameter reduction compared with no statin patients (18% vs. 3%, P = 0.03 and 11 mm (IQR 4) vs. 6 mm (IQR 4), P = 0.05, respectively). Freedom from growth diameter and reintervention rate were not significantly different (85 ± 9% vs. 81 ± 14%, P = 0.10 and 75 ± 17% vs. 37 ± 16%, P = 0.13, respectively). Conclusion Statin therapy seems to influence T2E regression and aortic sac stabilization after EVAR in the early medium follow-up; however, prospective studies need to confirm the present results

Characterization of Vessel Deformations During EVAR: A Preliminary Retrospective Analysis to Improve Fidelity of Endovascular Simulators

Objective: During endovascular aneurysm repair (EVAR), vessel deformations occur due to the insertion of tools and deployment of stent grafts in the arteries. We present a method for the characterization of vessel deformations during EVAR, and its application on patient datasets for a preliminary retrospective analysis that may be used to improve fidelity of endovascular simulators. Design: The method provides the extraction of vessel profiles from intraoperative fluoroscopic images and the calculation of a tortuosity index in the 2D fluoroscopy view (\ucf\u842D) used to quantify the vessel deformations (\uce\ub4%) during EVAR caused by the stiff guidewire insertion (\uce\ub4%Stiff) and the stent graft deployment (\uce\ub4%Graft), when compared with the undeformed vessel configuration (no device inserted). We applied the method to analyze retrospectively 7 EVAR patient datasets, including vasculature anatomies with different grades of vessel tortuosity or calcification: 2 patients (Pts) with absent tortuosity and mild calcification, 2 with mild tortuosity and mild calcification, 2 with severe tortuosity and mild calcification, and 1 with severe tortuosity and severe calcification. The analysis was focused on deformations of the left common iliac artery (LCIA), which is one of the arterial segments most affected by deformations. Results: In patients with mild LCIA calcification, the vessel straightening effect due to the stiff guidewire insertion increases as the severity of LCIA tortuosity increases (\uce\ub4%Stiff= 0 \uc2\ub1 2%, -19 \uc2\ub1 2%, -45 \uc2\ub1 2% for absent, mild, and severe tortuosity, respectively). In patients with mild/severe LCIA tortuosity, the artery with the deployed graft seems to retain part of the straightening effect caused by the stiff guidewire (\uce\ub4%Graft= -9 \uc2\ub1 3%, -31 \uc2\ub1 2%, for mild and severe tortuosity, respectively). In case of severe LCIA calcification, the stiff guidewire causes only a slight straightening effect (\uce\ub4%Stiff= -12%) despite the severe vessel tortuosity. Conclusion: The method was effective in characterizing real vessel deformations during EVAR. Results gave evidence of a relationship between the obtained deformations and the anatomical vessel conformation. These results may be useful to drive predictive models of vessel deformations during EVAR to be implemented in endovascular patient. -specific simulators for improving their fidelity

Impact of previous open aortic repair on the outcome of thoracoabdominal fenestrated and branched endografts

Background: Thoracoabdominal aortic aneurysms (TAAAs) after previous aortic open surgical repair (OSR) are challenging clinical scenarios. Redo-OSR is technically demanding, and standard endovascular repair is unavailable due to visceral vessel involvement. Fenestrated and branched endografts (FB-EVAR) are effective options to treat TAAAs in high surgical risk patients but dedicated studies on the FB-EVAR outcomes in patients with TAAAs with previous OSR are not available. The aim of the study was to evaluate the impact of previous OSR on TAAAs FB-EVAR outcomes. Methods: Between 2010 and 2016, all TAAAs undergoing FB-EVAR were prospectively evaluated, retrospectively categorized in two groups, and then compared: group A–primary TAAAs and group B–TAAAs after previous OSR (abdominal, thoracic, or thoracoabdominal aneurysm). Early end points were technical success (absence of type I-III endoleak, target visceral vessel loss, conversion to OSR, intraoperative mortality), spinal cord ischemia (SCI), and 30-day mortality. Follow-up end points were survival, target visceral vessel patency, and freedom from reinterventions. Results: Sixty-two patients (male: 74%; age: 72 ± 7 years) with 1 (1%) extent I, 14 (23%) extent II, 24 (39%) extent III, and 23 (37%) extent IV TAAA underwent FB-EVAR. The mean TAAA diameter and total target visceral vessels were 65 ± 13 mm and 226, respectively. Ninety branches and 136 fenestrations were planned. Thirty cases (48%) were clustered in group A and 32 (52%) in group B. Patients in group A and group B had similar preoperative clinical and morphologic characteristics, except for female sex (group A: 40% vs group B: 13%; P = .02). Technical success was 92% (group A: 90% vs group B: 94%; P = .6), SCI 5% (group A: 10% vs group B: 0%; P = .1) and 30-day mortality 5% (group A: 10% vs group B: 0%; P = .1). The mean follow-up was 17 ± 11 months with a total survival of 86%, 80%, and 60% at 6, 12, and 24 months, respectively and no differences in the two groups (group A: 83%, 83%, and 67% vs group B: 88%, 78%, and 55% respectively; P = .96). There was no late TAAA-related mortality. Target visceral vessel patency was 91%, 91%, and 91% at 6, 12, and 24 months, respectively (group A: 87%, 87%, and 87% vs group B: 95%, 95%, and 95%; P = .25). Freedom from reinterventions was 90%, 87%, and 87%, at 6, 12, and 24 months, respectively, and it was significantly lower in group A compared with group B (group A: 83%, 76%, and 76% vs group B: 96%, 96%, and 96% respectively; P = .002). Conclusions: Previous open surgery repair does not significantly affect the early outcomes of FB-EVAR in TAAA, with encouraging results in terms of technical success, SCI, mortality, and lower reinterventions rate at midterm follow-up

Predictors of perioperative and late survival in octogenarians undergoing elective endovascular abdominal aortic repair

Objective: The appropriateness of endovascular aneurysm repair (EVAR) of uncomplicated abdominal aortic aneurysm depends on the risk-benefit ratio, particularly in elderly patients with short life expectancy. The aim of this study was to assess the efficacy of EVAR in &gt;80-year-old patients by evaluating their postoperative survival and analyzing the possible predictors of late mortality. Methods: All consecutive patients aged &gt;80 years undergoing elective EVAR from 2006 to 2015 were prospectively evaluated. The 30-day mortality and long-term survival were assessed, and independent risk factors for mortality were determined by multivariate logistic and Cox analysis. Results: Of a total of 1135 EVARs performed in a 10-year period, 201 (18%) occurred in patients older than 80 years. The median age was 84 years (interquartile range, 3 years), and 85% were male. Thirty-four patients (17%) had a score of 4 according to the American Society of Anesthesiologists (ASA) classification. Overall 30-day mortality was 2% (n = 4); it was significantly higher in those with ASA score of 4 compared with ASA score &lt;4 (9.4% vs 0.6%; P =.04) and was also confirmed by multivariate analysis (odds ratio, 12.7; 95% confidence interval [CI], 1.1-141.8; P =.04). The mean follow-up was 36 \ub1 18 months, and the overall survival at 1 year, 3 years, and 5 years was 85% \ub1 2%, 77% \ub1 3%, and 52% \ub1 4%, respectively. Using multivariate Cox regression, ASA score of 4 and peripheral artery obstructive disease (PAOD) were the only independent predictors for midterm mortality (hazard ratio of 2.0 [95% CI, 1.2-2.9; P =.04] and 3.07 [95% CI, 1.06-5.2; P =.04], respectively). The 2-year survival was significantly influenced by the presence of both (ASA score of 4 and PAOD; survival, 33% \ub1 2%) or one (ASA score of 4 or PAOD; survival, 67% \ub1 8%) of the two independent predictors. If neither ASA score of 4 nor PAOD was present, survival was significantly improved (92% \ub1 3%; P =.02). Conclusions: The performance of EVAR in &gt;80-year-old patients is associated with an overall early mortality rate as low as 2%. In patients with no or only one risk factor, the survival rate warrants the treatment of abdominal aortic aneurysm; in contrast, patients with ASA score of 4 and PAOD have a significantly higher mortality rate and reduction of life expectancy

Proximal aortic neck angle does not affect early and late EVAR outcomes: an AnacondaTM Italian Registry analysis.

AIM: The aim of this paper was to evaluate early and 3-year results of the endovascular repair (EVAR) for abdominal aortic aneurysm (AAA) using the AnacondaTM endograft in patients with severe proximal aortic neck angle. METHODS: A retrospective analysis of the AnacondaTM Italian Registry was carried out. Two groups of patients were identified according to the presence of a severe (Group A, GA: 65 60\ub0) or an absent (Group B, GB: <45\ub0) proximal aortic neck angle. Preoperative, procedural and follow-up data were evaluated. Mortality, proximal type I endoleak, freedom from iliac leg thrombosis and conversion to open repair were analyzed at 30-day and 3-year follow-up. The results of GA and GB were compared. RESULTS: From 2005 to 2012, 1030 patients were enrolled in the Registry. Sixty-five patients (6.3%) were included in GA and 737 (71.5%) in GB. The mean age and AAA diameter were respectively 76.8 years and 62.7 mm in GA and 77.2 years and 56.5 mm in GB (P=NS). The ASA 65 3 was reported in the 95.3% of GA vs. 81% of GB (P=0.005). The endograft main-body was repositioned in 35% of cases in GA and 20.7% in GB (P=0.008); there were no differences in the main-body ballooning and proximal aortic cuff placement. There were no statistical differences in 30-day mortality (GA 1.5% vs. GB 1.3%), proximal type I endoleaks (GA 1.5% vs. GB 0.8%), iliac leg thrombosis (GA 1.5% vs. GB 1.4%) and conversion to open repair (GA 3% vs. GB 0.6%). The 3-year survival was 95.4% in GA and 94.7% in GB (P=NS). Freedom from proximal type I endoleak, iliac leg thrombosis and conversion to open repair were respectively 98.5%, 95.4%, and 95.4% in GA and 97.8%, 96.9%, and 98.5% in GB (P=NS). CONCLUSION: The AnacondaTM Italian Registry reports good results in terms of clinical success at 3-year follow-up. AAA with severe proximal aortic neck can be treated with similar outcomes to AAA with favorable neck anatomy. The endograft repositionability is a benefit in cases with severe neck angle

Renal Artery Orientation Influences the Renal Outcome in Endovascular Thoraco-abdominal Aortic Aneurysm Repair

Objective: To evaluate the impact of renal artery (RA) anatomy on the renal outcome of fenestrated-branched endografts (FB-EVAR) for thoraco-abdominal aortic aneurysms (TAAA). Methods: Between 2010 and 2016, all patients undergoing FB-EVAR for TAAA were prospectively collected. Anatomical, procedural, and post-operative data were retrospectively analysed. RA anatomy was assessed on volume rendering, multi planar and centre line reconstructions by dedicated software (3Mensio). RA diameter, length, ostial stenosis/calcification, orientation and aortic angles of the para-visceral aorta were evaluated. RA orientation was classified in four types: A (horizontal), B (upward), C (downward), D (downward + upward). RA revascularisation by fenestrations or branches was considered. Inability to cannulate and stent RA (RA loss), early RA occlusion (within three months), and composite RA events (one among RA loss, intra-operative RA lesion, RA related re-interventions, RA occlusion) were assessed. Results: Seventy-three patients (male 77%; age 73 ± 6 years) with 39 (53%) type I, II, III and 34 (47%) type IV TAAA, underwent FB-EVAR, for a total of 128 RAs. The mean RA diameter and length were 6 ± 1 mm and 43 ± 12 mm, respectively. Type A, B, C, and D orientations were 51 (40%), 18 (14%), 48 (36%), and 11 (10%) RAs, respectively. Angulation of para-visceral aorta >45° was present in 14 cases (19%). Ostial stenosis and calcifications were detected in 20 (16%) and 16 (13%) RAs, respectively. Branches and fenestrations were used in 43 (34%) and 85 (66%) RAs, respectively. There were four (3%) intra-operative RA lesions (2 ruptures, 2 dissections). Ten (8%) RAs were lost intra-operatively because of the inability to cannulating and stenting. On univariable analysis, type B RA orientation (p =.001; OR 13.2; 95% CI 3.2–53.6), para-visceral aortic angle > 45° (p =.02; OR 4.9; 95% CI 1.3–18.5) and branches (p =.003; OR 9.0; 95% CI 1.9–46.9) were risk factors for intra-operative RA loss; type C RA orientation was a protective factor (p =.02; OR 0.1; 95% CI 0.01–0.9). On multivariable analysis, type B RA orientation (p =.03; OR 5.9; 95% CI 1.1–31.1) and branches (p =.03; OR 7.3; 95% CI 1.1–47.9) were independent risk factors for intra-operative RA loss. Fourteen patients suffered post-operative renal function worsening (> 30% of the baseline). The mean follow up was 19 ± 12 months. Four (3%) early RA occlusions occurred in three patients (2 single kidney patients required permanent haemodialysis). Type D RA orientation (p =.00; RR 17.8; 8.6–37.0) and branches (p =.004; RR 3.2; 2.4–4.1) were risk factors for early RA occlusion on univariable analysis. Five patients (7%) required early RA related re-interventions (recanalisation + relining 3; stent graft extension 1; parenchymal embolisation 1). No late RA occlusion or re-interventions were reported during follow up. Composite RA events occurred in 17 (13%) cases. Type B (p =.05; OR 3.9; 95% CI 1.1–15.7) or D (p =.006; OR 10.9; 95% CI 2.3–50.8) RA orientations and branches (p =.006; OR 5.7; 95% CI 1.6–20.3) were independent predictors of composite RA events on multivariable analysis. Conclusion: Renal artery orientation significantly affects the early RA outcome of FB-EVAR for TAAA. Intra-operative RA loss is predicted by type B RA orientation and branches, while early RA occlusion is predicted by type D orientation and branches. The present data suggest that in TAAA, fenestrations should be the first choice for renal revascularisation in type B and D RA orientations